Quality Assurance through Regulations & Audit
As healthcare companies are becoming more inclined to value-based patient care, regulatory bodies have tightened the compliance requirements to increase transparency and ensure medical device quality and efficacy. With stricter norms and greater emphasis being given to patient safety, medical device manufacturers must establish processes to achieve compliance. ISD had obtained ISO13485 certification audited by TUV, Rhineland LGA Products, GMBH certification body. We also obtained approval from Malaysia Medical Device Authorities (MDA) on all SKYGEL® products.
Creating Culture of Quality and Staff Competency
in the organization
Quality begins with every employee and includes every process and procedure ranging from development to delivery. This involves implementing robust quality standard processes across the business. By Improving quality across operations and establishing a comprehensive control mechanism, medical device manufacturers can cultivate a culture of quality. ISD provide training to all staffs enable them to equip with the ISO 13485 and ISO 14971:2019 Risk Management for Medical Device knowledge.